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Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction (PAST-HFrEF)

9 września 2026 zaktualizowane przez: Guangyuan Song, Beijing Anzhen Hospital

A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction

To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a prospective, randomized, open-label, parallel-controlled, superiority, multicenter clinical study. A total of 208 subjects will be randomized 1:1 after meeting all inclusion/exclusion criteria.

Treatment Group: atrial shunt implantation post-right heart catheterization. Control Group: Right heart catheterization only. Both groups will receive standardized Guideline-Directed Medical Therapy (GDMT) post-procedure. Assessments and follow-ups will be conducted at pre-procedure baseline, day of procedure, 1 week, 1 month, 3 months, 6 months, and 12 months post-procedure.

A Clinical Event Committee (CEC), composed of third-party cardiovascular experts, will independently review and adjudicate primary endpoints in a blinded manner (surgical information concealed).

Typ studiów

Interwencyjne

Zapisy (Szacowany)

208

Faza

  • Faza 2
  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100029
        • Rekrutacyjny
        • Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 1. Age ≥ 18 years 2. Diagnosed with HFrEF and receiving Guideline-Directed Medical Therapy (GDMT) for at least 1 month 3. Echocardiographic LVEF between 20% and 40% (20 ≤ LVEF ≤ 40%) 4. Presence of HF-related symptoms and signs, NYHA Class III 5. At least one HF-related hospitalization in the past year or NT-proBNP ≥ 600 pg/mL (sinus rhythm) / ≥ 1000 pg/mL (atrial fibrillation) 6. Invasive hemodynamics: mLAP or mPCWP ≥ 15 mmHg, or left-to-right mean pressure gradient ≥ 5 mmHg 7. Fully understand the study design and follow-up schedule, agrees to participate, and voluntarily signs the Informed Consent Form

Exclusion Criteria:

  • 1. End-stage heart failure on the heart transplant waiting list (including meeting LVAD indications) 2. Three consecutive non-invasive systolic blood pressure readings < 90 mmHg 3. Primary structural valvular disease currently indicating surgery or interventional therapy, or severe coronary artery disease requiring revascularization 4. ECG QRS duration ≥ 130 ms with high risk of sudden cardiac death without therapeutic intervention (including meeting CRT/CRT-D indications) 5. Significant right ventricular (RV) dysfunction or severe pulmonary hypertension. Defined by clinical evidence of hepatic congestion, moderate-to-severe edema, or abdominal distension accompanied by poor appetite; significant right atrial or RV enlargement/dysfunction; moderate-to-severe tricuspid regurgitation; mean right atrial pressure > 10 mmHg; systolic pulmonary artery pressure > 60 mmHg; or pulmonary vascular resistance > 3 Wood Units 6. Myocardial infarction or cardiac intervention within the past 1 month 7. Stroke within the past 1 month (excluding lacunar infarction) 8. Decompensated liver cirrhosis (Child-Pugh Class B or worse), or severe chronic pulmonary disease requiring oxygen therapy 9. Anatomical abnormalities precluding procedure completion or making the patient unsuitable for procedure 10. Atrial thrombosis 11. Contraindication to antithrombotic therapy 12. Life expectancy < 1 year 13. Uncontrolled active infection 14. Pregnant, lactating, or women of childbearing potential planning pregnancy in the near future 15. Currently participating in another drug or medical device clinical trial 16. Investigator deems the patient unsuitable for this trial

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
Urządzenie: D-shant Atrial Shunt
The D-Shant atrial shunt device is a novel device therapy for heart failure, classified as a non-active implantable cardiovascular device. It is manufactured using a braided Nitinol technique, thermally set via assembly molds to form a waist with a fixed-orifice support and a hollow double-disc structure. Braided wires reinforce waist support and maintain a circular orifice shape. Once implanted, it forms a stable interatrial shunt. The device is delivered via the femoral vein to the interatrial septum, where the shunt orifice facilitates blood flow diversion and pressure decompression. Various models with different waist and disc diameters are available to accommodate varying degrees and etiologies of heart failure.
Lek: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Aktywny komparator: no Device group (Control Group)
Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only
Lek: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months
Ramy czasowe: From enrollment to the end of treatment at 12 months
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months. Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or <24 hours if subject dies in the emergency room). - Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay <24 hours. - Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy
From enrollment to the end of treatment at 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Ramy czasowe: From enrollment to the end of treatment at 12 months
Change in exercise capacity post-procedure: 6-Minute Walk Test
From enrollment to the end of treatment at 12 months
New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome）
Ramy czasowe: From enrollment to the end of treatment at 12 months
Change in New York Heart Association (NYHA) Functional Classification
From enrollment to the end of treatment at 12 months
Change in NT-proBNP levels
Ramy czasowe: From enrollment to the end of treatment at 12 months
Change in NT-proBNP levels
From enrollment to the end of treatment at 12 months
Left atrial diameter
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic Left atrial diameter
From enrollment to the end of treatment at 12 months
Device Success Rates (Treatment Group)
Ramy czasowe: From enrollment to the end of treatment at 12 months
Device Success is defined as successful implantation of the shunt with normal morphology and position, visible left-to-right shunt on echocardiography, and an immediate decrease in mean Left Atrial Pressure (mLAP) or mean Pulmonary Capillary Wedge Pressure (mPCWP) compared to pre-implantation.
From enrollment to the end of treatment at 12 months
Changes in 12-lead Electrocardiogram (ECG)
Ramy czasowe: From enrollment to the end of treatment at 12 months
Presence of arrhythmias
From enrollment to the end of treatment at 12 months
Shunt Orifice Patency/Occlusion Status (Treatment Group)
Ramy czasowe: From enrollment to the end of treatment at 12 months
Shunt Orifice Patency/Occlusion Status (Treatment Group)
From enrollment to the end of treatment at 12 months
All-cause mortality rate
Ramy czasowe: From enrollment to the end of treatment at 12 months
All-cause mortality rate
From enrollment to the end of treatment at 12 months
Number of HF-related rehospitalizations post-procedure
Ramy czasowe: From enrollment to the end of treatment at 12 months
Number of HF-related rehospitalizations post-procedure
From enrollment to the end of treatment at 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome）
Ramy czasowe: From enrollment to the end of treatment at 12 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
From enrollment to the end of treatment at 12 months
Right atrial diameter
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic right atrial diameter
From enrollment to the end of treatment at 12 months
Left ventricular diameter
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic left ventricular diameter
From enrollment to the end of treatment at 12 months
Right ventricular diameter
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic reft atrial diameter
From enrollment to the end of treatment at 12 months
Left Ventricular Ejection Fraction
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic Left Ventricular Ejection Fraction
From enrollment to the end of treatment at 12 months
Tricuspid Annular Plane Systolic Excursion
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic Tricuspid Annular Plane Systolic Excursion
From enrollment to the end of treatment at 12 months
Right Ventricular Fractional Area
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic Right Ventricular Fractional Area
From enrollment to the end of treatment at 12 months
Aortic regurgitation
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic aortic regurgitation
From enrollment to the end of treatment at 12 months
Mitral regurgitation
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic mitral regurgitation
From enrollment to the end of treatment at 12 months
Tricuspid regurgitation
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic tricuspid regurgitation
From enrollment to the end of treatment at 12 months
Shunt orifice diameter
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic Shunt orifice diameter
From enrollment to the end of treatment at 12 months
Shunt flow velocity
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic shunt flow velocity
From enrollment to the end of treatment at 12 months
Trans-shunt pressure gradient
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic trans-shunt pressure gradient
From enrollment to the end of treatment at 12 months
Shunt flow direction
Ramy czasowe: From enrollment to the end of treatment at 12 months
Echocardiographic shunt flow direction
From enrollment to the end of treatment at 12 months
Procedural Success Rates (Treatment Group)
Ramy czasowe: From enrollment to the end of treatment at 12 months
Procedural Success is defined as achieving Device Success with the patient surviving to hospital discharge.
From enrollment to the end of treatment at 12 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Device-Related Adverse Events
Ramy czasowe: From enrollment to the end of treatment at 12 months
Cardiac tamponade Air embolism Systemic embolization syndrome Thrombus formation on the device surface Device malfunction requiring emergency surgical removal
From enrollment to the end of treatment at 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beijing Anzhen Hospital

Współpracownicy

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Śledczy

  • Główny śledczy: Guangyuan Song, M.D., Beijing Anzhen Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

25 listopada 2024

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

31 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

16 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 września 2026

Pierwszy wysłany (Rzeczywisty)

15 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • BeijingAnzhen20260716

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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